agency
EP Chapter 2.6.30
Quality Level
feature
ready-to-use
packaging
pkg of 2 vials
manufacturer/tradename
PyroMAT®
application(s)
pharmaceutical
pyrogen testing
compatibility
configured for PyroMAT® System
shipped in
dry ice
suitability
pyrogenic bacteria
General description
The PYROMAT® system is a robust, easy-to-perform and ready-to-use solution for pyrogen testing, using the Monocyte Activation Test (MAT). The PYROMAT® cells are cryopreserved human monocytic cells from the Mono-Mac-6 cell line. They have been validated to be used for MAT.
The PyroMAT® System is based on the Mono-Mac-6 (MM6) cell line and uses Interleukin-6 (IL-6) as a read out.
PyroMATcells contains the crypreserved MonoMac 6 cells, 2 x 1 mL
PyroMATcells contains the crypreserved MonoMac 6 cells, 2 x 1 mL
Application
PYROMAT® cells is used to determine the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes. It is used to ensure the safety of parenteral pharmaceutical products and medical devices.
Features and Benefits
- Cryopreserved ready-to-use monocytic cells
- The only cell line validated and available for the Monocyte Activation Test
- Expression of all the Toll-like Receptors responsible for pyrogen detection
Packaging
1 box of 2 vials, sufficient for 1 test
Other Notes
2 vials of cryopreserved Mono-Mac-6 cells
Download the PyroMAT® Method Software from here.
To be used with PyroMAT kit (PYR0MATKIT), Reference standard endotoxin (144.161.0001), NEP controls (MATHKSA, MATFLAGELLIN)
Legal Information
PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany
Disclaimer
Due to the sensitivity of the product adding a temperature data logger is required. Please make sure to add one DATAL0GGER95 per every 18 packages of PyroMAT® cells.
signalword
Warning
hcodes
Hazard Classifications
Skin Sens. 1
存储类别
10 - Combustible liquids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
监管及禁止进口产品
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商品
Yeast plasmid selection: Utilizes auxotrophic yeast strains for plasmid selection, enabling growth on synthetic media for better yield.
Overview of primary cells and media usage in biomedical culture applications highlights differences from cell lines.
什么是原代细胞？关于动物和人类原代细胞系和培养基的全面概述，以及它们如何应用于生物医学细胞培养应用。相对于细胞系，原代培养物的均一性较低。
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| PYR0MATCELLS | 04054839404764 |